Efficacy and Safety of b-2Cool on Adults With Joint Discomfort

NCT02843620 | Withdrawn DMC

• 1 other identifier: PRJ290
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effects of 40 mg of b-2Cool, a food supplement rich in native type-II collagen, on healthy adults with joint discomfort. Half of the participants will receive the b-2Cool containing supplement while the other half will receive a placebo pill.

Conditions

Joint Discomfort

Keywords

Native Collagen; Joint; Joint Discomfort

Outcome Measures

Primary Outcomes (1)

• Change from baseline of ultrasonographic assessment of synovial effusion

  0, 6, 12 and 24 weeks

Secondary Outcomes (7)

• Visual Analog Scale (VAS) pain evaluation

  0, 6, 12 and 24 weeks

• WOMAC Functional assesment

  0, 6, 12 and 24 weeks

• Subjective evaluation of quality of life

  0, 6, 12 and 24 weeks

• Collagen degradation markers in urine

  0, 12 and 24 weeks

• Patient's satisfaction

  6, 12 and 24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo arm will take a pill each day containing only excipients

Other: Placebo

b-2Cool

EXPERIMENTAL

The b-2Cool arm will take a pill each day containing 40 mg of b-2Cool and excipients

Dietary Supplement: b-2Cool

Interventions

b-2Cool DIETARY_SUPPLEMENT

b-2Cool® is native type II collagen extracted from chicken sternums

b-2Cool

Placebo OTHER

Excipients only

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 40 and 75 years old.
• Subject who suffers mild joint discomfort (value between 3 and 5 VAS scale for a minimum of 6 months).
• Subject that after reading and understanding the study's protocol has provided written informed consent to participate in the study.
• Subjects willing to keep stable eating and activity patterns during the duration of the study.
• Subjects who use other therapies for joint discomfort, such as exercise, heat / cold, joint protection and physiotherapy / occupational therapy agree to follow the treatments avoiding changes in the frequency or intensity of them and reporting them at baseline and during follow-ups.
• Subjects agree not start any new therapy during the study period.
• Subjects who have lateral or longitudinal knee synovial effusion according to the index OMERACT (Outcome Measures in Rheumatology) .

You may not qualify if:

• Active rheumatoid arthritis, diagnosed osteoarthritis or any other inflammatory arthritic condition that researchers consider non appropriate.
• Being pregnant or lactating.
• Be waiting for joint surgery or major surgery in the next 8 months
• Joint injury in the last 4 months in the area osteoarthritis-affected (i.e. meniscal tear)
• Having underwent reconstructive surgery on the cartilage of the affected knee
• Background of peptidic ulcer and other symptomatic/active disorders of the intestinal tract that may interfere with product under evaluation .
• History of congestive heart failure,
• Allergy to chicken or other ingredients in the product
• Anticipated problems with product consumption
• High alcohol consumption (\> 2 drinks per day)
• History of psychiatric disorders that may impede the ability of subjects to give written informed consent
• Failure to comply with washout periods before the start of the study.
• Paracetamol intake 24 hours before randomization
• The subject does not want to stop taking medication in addition to the study medication (for arthritis or other pain) or not to take other types of medication for the treatment of osteoarthritis pain
• Other conditions that, in the opinion of the principal investigator adversely affect the subject's ability to complete the study or its measures

Sponsors & Collaborators

• Bioiberica: lead

Study Officials

• Ingrid Möller, Dr.

  Instituto Poal de Reumatología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 26, 2016
• Study Start: July 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07